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Thermo Fisher Scientific · 14 hours ago

Technical Writer - GMP

United States

Full-time

Remote

Entry Level

2+ years exp

Thermo Fisher Scientific is a global leader in serving science, and they are seeking a Technical Writer to assist in the preparation and review of scientific documents. The role involves writing and editing analytical methods, reports, and protocols to meet regulatory standards, ensuring quality and accuracy in documentation.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

Responsibilities

Prepares and/or assists in the preparation of scientific documents such as methods, protocols, reports, method development summaries, analytical methods, SOPs, client correspondence and other similar documentation

Compiles laboratory data into a specified report format. Ensures that hardcopy and electronic reports are consistent and comply with required formats. Reviews data tables and listings and ensures that errors are corrected. Performs a quality control review of scientific documents prior to creation of the final pdf deliverable. Ensures compliance with PPD, Client, eCTD policy and procedure on publications

Reviews scientific documents for accuracy, formatting, consistency and compliance to protocols or SOPs

Works with senior staff to determine approach for new assignments

Keeps updated on the guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents

Performs other duties as assigned

Qualification

Scientific terminologyWord processing softwareIndustry regulations knowledgeAnalytical laboratory proceduresEditorial skillsEffective communicationDetail orientedTime managementProblem solvingTeam collaboration

Required

Must be legally authorized to work in the United States without sponsorship

Must be able to pass a comprehensive background check, which includes a drug screening

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') or equivalent combination of education, training, & experience

Good working knowledge of scientific terminology, medical, pharmaceutical and research concepts

Good knowledge of word processing, spreadsheets, table and graph generation and use of applicable computer software

Working knowledge of industry regulations, ICH or other regulated environments

Working knowledge of analytical laboratory procedures

Effective written and oral communication skills

Detail oriented

Time management skills

Good editorial and proofreading skills

Good problem solving and troubleshooting abilities

Ability to work well in a collaborative team environment

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner

Able to work upright and stationary for typical working hours